(56 days)
Not Found
No
The summary describes a chemical etchant for dental use and does not mention any computational or algorithmic components, let alone AI/ML.
No
This device is an etchant used to prepare teeth for bonding, which is a procedural aid, not a device used to treat or prevent a disease or condition.
No
Explanation: The device is an etchant used to prepare teeth for bonding resins or sealants. Its function is to remove the smear layer, which is a treatment step, not a diagnostic one. It does not identify or characterize a disease or condition.
No
The device description clearly states it is a phosphoric acid semi-gel-type agent, indicating it is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for etching dentin and enamel as a pretreatment before bonding with resin or sealant. This is a direct application to the patient's teeth for a therapeutic or restorative purpose.
- Device Description: The device is a phosphoric acid gel applied to the tooth surface.
- Lack of Diagnostic Purpose: IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimen for diagnostic purposes.
The device is a dental material used in a clinical setting for a restorative procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
- Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
- Remove smear layer of dentin and enamel
- Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin and enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
pH, viscosity, shape retention functions and etching effect test were conducted for non clinical tests. The performance of FineEtch is compared with K-Etchant gel (predicate device) and ScotchbondTM Universal Etchant (other dental etchant). The test results showed that the subject device is as good as the predicate device. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device and other dental etchant in the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 1, 2024
Spident Co., Ltd. Eunok Choi RA Manager 203 & 312, Korea Industrial Complex, 722 Gojan-Dong, Namdong-Gu Incheon, Incheon 405-821 Korea, South
Re: K242675
Trade/Device Name: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE Dated: September 3, 2024 Received: September 6, 2024
Dear Eunok Choi:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 5ml, FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
Indications for Use (Describe)
· Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
· Remove smear layer of dentin and enamel
• Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K242675
Image /page/4/Picture/1 description: The image is a logo for SPIDENT. The logo is green and features the word "SPIDENT" in a bold, sans-serif font. The letters are arranged horizontally, and the entire word is enclosed in a square shape. The square is also green and has rounded corners.
SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821
Tel : +82-32-821-0071 Fax : + 82-32-821-0074
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: September 20, 2024
1. Company and Correspondent making the submission:
Company Name : SPIDENT CO., LTD. Address : 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074 Company Contact : Eunok Choi/RA Manager
2. Device Name and Classification
Device Trade Name : FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) Common name : Dental etchant Classification name : Resin tooth bonding agent [CFR 872.3200] Product code : KLE Class : II
3. Predicate Devices (Legally Marketed Devices)
The predicate devices for FineEtch is :
- · K-ETCHANT GEL, KURARAY MEDICAL INC., K062409
4. Device Description:
FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
5
Image /page/5/Picture/0 description: The image shows the logo for SPIDENT. The logo is green and features the word "SPIDENT" in a bold, sans-serif font. The letters are all capitalized and are a bright green color. A green square surrounds the word, with the top and bottom lines of the square extending beyond the letters on either side.
5. Indications for Use
- · Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
- . Remove smear layer of dentin and enamel
- . Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)
6. Indications for Use Comparison
The indication for use of the subject device are all included in the indication for use of the predicate device (Etching the enamel and dentin for adhesive restorations). There are some differences in expression, but they both can be used as a pretreatment before resin and sealant. Also, both can be used to remove smear layer of dentin and enamel.
7. Technological Comparison
Principle Operation, Biocompatibility, Application Area. Target Population of subject device and predicate device are the same. The performance results of the subject device and predicate device is similar.
Also, both subject device and predicate device have the similar intended operator. In case of storage condition, both products have similar limit of temperature. Therefore, FineEtch is substantially equivalent with predicate device, K-ETCHANT GEL,
and at least as safe and effective as the predicate device.
8. Performance Testing-Non Clinical tests
pH, viscosity, shape retention functions and etching effect test were conducted for non clinical tests. The performance of FineEtch is compared with K-Etchant gel (predicate device) and Scotchbond™ Universal Etchant (other dental etchant).
The test results showed that the subject device is as good as the predicate device. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device and other dental etchant in the market.
9. Performance Testing-Clinical tests
Not Applicable
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Image /page/6/Picture/0 description: The image shows the logo for SPIDENT. The logo is green and features the word "SPIDENT" in a bold, sans-serif font. The word is enclosed in a square shape, with the top and bottom lines of the square extending beyond the sides of the word. The logo is simple and modern, and the green color gives it a fresh and clean look.
SPIDENT CO., LTD. 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel : +82-32-821-0071 Fax : + 82-32-821-0074
10. Conclusion
Based on a comparison of subject device, FineEtch (SPIDENT CO., LTD.) and predicate device, K-ETCHANT GEL (KURARAY MEDICAL INC.), it is confirmed that the subject device is substantially equivalent to predicate device.